A Randomised Proof-of-Principle Trial Investigating Pharmacodynamics, Pharmacokinetics, and Safety of NNC0143-0406 in Subjects With Type 1 Diabetes Mellitus

What Was Tested

In this phase 1 trial, researchers set out to test Insulin Aspart.

This trial is conducted in Europe.

It had two arms (groups): NNC0143-0406 (experimental) and Insulin aspart (active comparator).

The registry classes the interventions as drug.

Who Took Part

The registry lists 47 actual participants took part.

It was open to people of any sex aged from 18 years up to 55 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Male or female aged 18-55 years (both inclusive) at the time of signing informed consent. Subjects diagnosed (clinically) with type 1 diabetes mellitus at least 365 days prior to the day of screening. Treated with continuous subcutaneous insulin infusion at least 90 days prior to the day of screening.

The full record lists 3 inclusion and 3 exclusion criteria; among the exclusions: known or suspected hypersensitivity to trial product(s) or related products.

How the Study Was Run

It was run as a randomized, crossover and double-blind study.

The participants were allocated by chance, so the Insulin Aspart group and the comparison group should start out alike.

Each person switched between Insulin Aspart and the comparison at some point, usually with a gap in between.

Neither the participants nor the staff measuring them knew who was on Insulin Aspart, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant and investigator.

It started in 2016-10-19 with completion listed for 2017-06-17.

It ran at 1 site in Austria.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: The ratio of suppression of endogenous glucose production relative to total glucose lowering effect (time frame: Two weeks of treatment).

It also tracked 1 secondary outcome, for example Number of treatment emergent adverse events.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Insulin Aspart in 47 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Insulin Aspart compound page, all human trials.